Aseptic Pharmaceuticals Manufacture
We offer production of sterile drug products for clinical trials and commercial supply using aseptic processing.
Our comprehensive service offering includes the capability for producing sterile drug products, utilising full disposable systems and meeting rigorous sterility requirements in accordance with aseptic manufacturing procedures.
With batch sizes from 1 to 100 litres, Cobra can manufacture for clinical trials through to commercial scale supply, with parenteral products filled in syringes or vials.
All batch records are fully traceable under QA observation with QP review and issue of GMP Certificate of Compliance, and regulatory documents are reviewed as required to support product release to clinic. Primary labelling of drug product vials / syringes for human clinical centres, secondary packaging and labelling of vials / syringes for dispatch to clinical centres, and tertiary and transport labelling and packaging can also be arranged according to regulatory requirements.
Vial Fill Finish
Vials from 2ml to 100ml can be filled in our aseptic processing line operating under EU grade A with grade B surrounding in batch sizes up to 20,000 units.
Pre-Filled Syringe Fill Finish
Pre-sterilised, pre-filled, syringes ranging from 0.5ml to 10ml can be filled in our aseptic processing line operating under EU grade A with grade B surrounding in batch sizes up to 30,000 units.
In response to customer demand, we have recently invested in an expansion of our capabilities to include a 1ml long syringe format for batches up to 20,000 units. Today ~80% of the prefilled market for high value, low volume biologicals utilises this format.
DP Freeze Drying / Lyophilisation in Vials
Vials can also be lyophilized to enhance product stability. Depending on vial size Cobra offers lyophilisation of batches in the range from 1,060 to 14,400 units.
Our purpose built aseptic manufacturing facility in Matfors, Sweden is perfectly equipped for automated filling of both single-use pre-filled syringes or injection vials with the additional benefit of GMP freeze drying, if required.
Get In Touch
Speak to a member of our expert team and arrange to take a tour of our Fill Finish Facility in Matfors, Sweden.